US20180126072A1 - Infusion and blood collection devices and methods - Google Patents

Abstract

An infusion and blood collection device allows clean blood collections into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies after initial installation. The device optionally includes passive control of the blood collection flow rate to prevent contamination of the collected blood draw with the IV therapy fluid being simultaneously infused through the angiocatheter. A blood collection method uses an infusion and blood collection device to draw a clean blood sample from a patient and into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 14/145,717, filed Dec. 31, 2013, which claims the benefit of U.S. Provisional Application No. 61/747,815, filed Dec. 31, 2012, the entireties of which are hereby incorporated herein by reference. Any disclaimer that may have occurred during the prosecution of the above-referenced application(s) is hereby expressly rescinded.
BACKGROUNDField of the Invention
• The present invention relates to an infusion and blood collection device and method. In particular, the present invention is directed to an infusion and blood collection device that allows clean blood collections via an angiocatheter previously installed to administer intravenous fluids. The present invention is also directed to a method of using the infusion and blood collection device to draw blood from a patient via a previously installed angiocatheter.
Description of Related Art
• U.S. Pat. No. 3,610,226 to Albisser discloses a double lumen cannula instrument for the withdrawal of blood over a prolonged period of time. The instrument includes an inner lumen for withdrawing blood and an outer lumen for introducing an anticoagulant diluent. The relative locations of the openings for the inner and outer lumen permit the mixing of the diluent with the withdrawn blood.
• U.S. Pat. No. 5,374,245 to Mahurkar discloses an extruded reinforced multiple-lumen catheter for use in medical applications where fluids must flow simultaneously to and from a patient. Blood is withdrawn for a medical procedure (e.g. dialysis) from the patient through one passageway and returned to the patient through another passageway spaced from the first passageway.
• U.S. Pat. No. 5,607,401 to Humphrey discloses augmented polymeric hypodermic needles and lancets. The polymeric needles and lancets are stiffened by augmenting means, which includes a slidable guard or foam insert so that they are able to pierce the skin. Without the augmenting means, it is not possible for the polymeric hypodermic lancet to pierce the skin.
• U.S. Pat. No. 5,637,399 to Yoshikawa et al. discloses an extruded synthetic resin needle that is reinforced with combustible fibers. The needle provides a single path administering or withdrawing fluids from a patient.
• The prior art described above does not provide for a catheter assembly that is capable of prolonged insertion in the patient for both the simultaneous administering of intravenous fluids and the periodic withdrawal of blood without mixing the intravenous fluid with the withdrawn blood.
• U.S. Pat. No. 6,758,835 to Close et al. discloses a micro-injection molded disposable needle assembly having more than one passageway formed therein to permit the simultaneous drawing and administering of fluids through separate passageways. The micro-injection molded disposable assembly includes one or more sensors disposed therein for measuring and monitoring one or more desired body or surrounding environmental conditions. It also discloses a method of forming the disposable needle from an elastomeric material using micro-injection molding.
• The invention herein is partly an extension of the device and method disclosed in U.S. Pat. No. 6,758,835 to Close et al. Accordingly, the disclosure of U.S. Pat. No. 6,758,835 is incorporated herein by reference in its entirety.
• The devices described in the above prior art focus primarily on the catheter portions of needle assemblies that are capable of prolonged insertion in patients for both the simultaneous administering of intravenous fluids and the withdrawal of blood without mixing the intravenous fluid with the withdrawn blood.
• Unlike the above prior art, the invention herein does not focus primarily on the catheter portion of the needle assembly. Instead, it provides a device that may be inserted between a standard, previously installed intravenous (IV) catheter and a standard IV infusion line, and permits the performing of clean blood collections without interrupting the administering of IV therapy to the patient. For example, IV infusion pumps are typically stopped for 30 seconds or more for any blood collection obtained from the peripheral catheter and the connection between the IV catheter and infusate line are disconnected in order to pull the blood sample through the IV catheter and avoid infusate mixing with the blood collection that can cause erroneous results. If the IV infusion pump is not stopped and a downstream valve (e.g., a 2-, 3-, or 4-way stop cock valve) is used to stop the infusate administration, then a pump alarm this sets off, requiring staff attention because the line is considered occluded. Such fluid infusion restriction alarms on IV infusion pumps are typically triggered when the fluid being infused increases to over 10 psi. Providing a device that avoids interruption of the IV therapy prevents stopping the IV infusion pump or triggering an infusion restriction alarm. Further, the device herein has the purpose of reducing the complexity of the flow transfer portion of commonly used infusates and blood collection devices. Thus, whereas in some of the above prior art the pressure is sensed and controlled actively to ensure a clean blood collection, in the instant invention, the pressure can be controlled passively, or alternatively or additionally, actively.
• When a patient is admitted into a hospital, an emergency room, or some other medical facility, in the vast majority of cases the patient receives an IV catheter of one kind or another. In some instances, the IV catheter is put in place right away upon admission to administer a needed therapy to the patient. In other instances, the IV catheter is put in place simply for risk management reasons, so as to have the catheter ready in case the medical care providers need to quickly administer medications or fluids to the patient. The cannula portion of the IV catheter is placed into a blood vessel, typically in the forearm, hand, or another location in the patient's body, and the connection portion of the IV Catheter to allow IV infusion is typically secured to the outside of the patient's body with any of a variety of available tapes, bands, straps, or other means.
• The typical hospital stay for a patient, on average, is around three days, during which it is reported that two or more sets of laboratory tests per day may be carried out on average. This means that at least twice a day a medical technician would have to subject the patient to a blood collection, which is then sent to the laboratory for testing and/or analysis. Usually if the patient already has a catheter strapped in place in one arm via which medications or fluids are being administered, the medical technician would have to use the patient's other arm or another part of the patient's body to perform blood collections. This means that, during a patient's 3-day average hospital stay, there are at least six occasions for the patient to be repeatedly stuck with a needle, which translates into at least six occasions for potential infections to start, hematomas, missed sticks, and skin irritation from tapes and other means. Furthermore, especially in situations involving pediatric patients, hemophiliac patients, HIV patients, patients with dementia and/or similar conditions, and/or other agitated patients who may suffer from fear of needle pricks, or having other elevated risks relating to additional needle insertions, the patient may be subjected to trauma on at least six occasions during their hospital stay, making the blood collection process difficult or otherwise risky.
• Moreover, in some situations, the medical technician may use a catheter already installed into the patient's body to draw blood for testing. In those situations, the technician typically has to temporarily discontinue administration of medications or fluids, and perform a lengthy, drawn-out series of flushing steps to guard against incidental contamination of the blood sample with residual IV solutions, medications or fluids, and ensure that the blood sample is clean. Without such flushing steps, a blood sample may, for example, be diluted with a residual IV solution, leading to erroneous test results. Likewise, for example, contamination of the blood sample with a residual IV solution that contains sodium and/or potassium compounds, would result in false test data showing higher concentrations of these compounds.
SUMMARY
• As will become apparent in the following disclosure, it is believed that the device and method of the invention described herein provide the advantage of alleviating and solving all of the foregoing blood-draw problems and issues. The device herein takes advantage of an already installed IV catheter port in a patient's body, and provides a simple procedure to perform clean drawing of blood without interrupting the administration of IV therapies after initial installation of the catheter. The device optionally includes passive control of the blood collection volume flow rate to prevent contamination of the collected blood draw with the IV therapy fluid being simultaneously infused through the catheter. The device herein is simply installed by inserting it into the IV catheter line already installed into the patient, and makes the procedural steps of drawing blood samples almost automatic. Furthermore, the device herein has the advantage of using the vacuum within a standard blood collection container, such as a Vacutainer® (trademark of Becton, Dickinson and Company, of Franklin Lakes, N.J.) or Vacuette® (trademark of Greiner Bio One, of Monroe, N.C.) tube, as the driving mechanism for drawing the blood sample from the patient.
• In an illustrative embodiment of the device (with distal/proximal references to the device, not the patient's body), a microlumen is inserted coaxially through and protrudes distally out from the distal end of a catheter which is inserted into a patient. The microlumen and catheter are in fluid communication with a diverter valve and valve housing. The valve housing is supplied with IV therapy fluid from an infusion line and provides selective operation in an infusion/non-collection mode and an infusion/collection mode. In the infusion/non-collection mode, IV therapy fluid is provided to both the microlumen and the catheter. In the infusion/non-collection mode, a blood collection component, for example, a vacuum collection tube holder coupled to the collection body, receives blood from the catheter and the microlumen simultaneously continues to provide IV therapy fluid to the patient.
• The protrusion length and blood collection flow rate are of significant importance to the invention herein, in order to prevent mixing, and thus contamination, of the drawn blood with the IV fluids in the infusion/collection mode. For example, the difference in pressures between a vacuum blood collection tube and a typical patient's vein pressure is approximately 2 orders of magnitude difference. For example, the tube vacuum can be as much as about 700 mmHg of vacuum and the vein pressure can be about 7 mmHg Thus, the mixing of collected blood with IV fluids at the point of collection in the vein is prevent by a combination of 1) the device limiting the flow rate of blood collection drawn from the vein and into the catheter and 2) the distal end of the microlumen used to simultaneously infuse infusate into the vein is sufficiently distal in the vein of the distal end of the IV catheter where blood is drawn from the vein.
• While the illustrative embodiment of the instant invention is directed to an angiocatheter (i.e., an IV catheter), it is to be understood that, as contemplated herein, the invention may be applicable to other catheters known in the art as well, such as peripherally inserted cardiac catheters, central catheter, and the like.
• It is an object of the present invention to provide an infusion and blood collection device that allows clean blood collections from a patient via a previously installed catheter, such as a Peripheral Venous Catheter, otherwise known as an angiocatheter, without interrupting the administration of intravenous therapies after the initial installation.
• It is another object of the present invention to provide an infusion and blood collection device that allows clean blood collections from a patient via a previously installed catheter, without having to resort to repeatedly sticking a patient with a needle at another location of their body away from the already installed catheter.
• It is another object of the present invention to provide an infusion and blood collection device that allows clean blood collections from a patient via a previously installed catheter, without exposing the patient to a higher risk of infection from repeated and multiple needle pricks.
• It is another object of the present invention to provide an infusion and blood collection device that allows clean blood collections from a patient via a previously installed catheter, wherein the patient is a pediatric patient, a hemophiliac patient, a HIV patient, a patient with dementia and/or a similar condition, and/or any patient who may be agitated or suffer from fear of needle pricks, or having other elevated risks relating to additional needle insertions.
• It is another object of the present invention to provide an infusion and blood collection device that allows clean blood collections from a patient via a previously installed catheter, without the need to temporarily discontinue administration of medications or fluids, and performing a lengthy, drawn-out series of flushing steps to guard against incidental contamination of the blood sample with residual IV solutions, medications or fluids.
• It is another object of the present invention to provide an infusion and blood collection device that allows clean blood collections from a patient via a previously installed catheter, in such a manner so as to reduce the time and patient care demands of hospital staff.
• The present invention relates to a blood-draw device and method that is used in conjunction with a pre-installed peripheral venous catheter/IV infusion line in a patient. An advantage of the device and method is being able to draw blood from the previously installed catheter without the need to interrupt IV flow.
• Another advantage of the device and method is the reduction in the number of venipunctures that have to be performed on a patient. This provides numerous potential advantages such as reduction in potential infection causing events, reduction in patient anxiety, reduction in time and patient care demands on the hospital staff, and reduction in disposal of bio-hazardous blood collection needle sets.
• Another advantage is having the blood collection access port of the device covered so as to prevent tampering with the port and bacterial transfers from the outside environment, which may either contaminate or damage the port, which in turn may lead to bodily injury.
• One illustrative embodiment of an infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient comprises a blood collection component having a draw inlet; a housing having an actuator and an IV infusion inlet coupled to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation for the device; a microlumen collocated with the patient catheter, the microlumen in fluid communication with the IV infusion inlet; a blood collection channel in fluid communication with the catheter, the blood collection channel directly accessible by the draw inlet of the blood collection component; and wherein in the infusion/non-collection mode the actuator fluidly couples the blood collection channel with the IV infusion inlet, and in the infusion/collection mode the actuator fluidly isolates the blood collection channel from the IV infusion inlet.
• The blood collection channel can be self-flushing with IV therapy fluid in the infusion/non-collection mode. The device can further comprising a passive restriction device limiting the volume flow rate of blood drawn by the catheter in the infusion/collection mode, thereby preventing mixing of the blood draw with IV therapy fluid provided through the microlumen. The blood collection component can be releasably attachable to the housing. The actuator can be actuated to the infusion/collection mode by engagement of the blood collection component with the housing and the actuator is actuated to the infusion/non-collection mode by disengagement of the blood collection component with the housing. The engagement can include axial and rotational movement of the blood collection component relative to the housing, the axial movement placing the draw inlet in fluid communication with the blood collection component and the rotation movement operating the actuator.
• The draw inlet can include a needle positionable to extend into the blood collection channel in the infusion/collection mode. The blood collection component can fluidly couple a vacuum blood collection tube to the blood collection channel. The actuator can include a rotary valve. The rotary valve can be a two-way valve and defines at least a portion of the blood collection channel. The draw inlet of the blood collection component can be extendable into the portion of the blood collection channel defined by the rotary valve. The microlumen can extend past the distal end of the catheter such that a distal end of the microlumen is located distally beyond the distal end of the catheter. The microlumen can be threaded coaxially through the catheter. The patient catheter can include a fluid catheter connector. The housing can include a fluid head connector for coupling to the catheter connector. The microlumen can exit the housing from within the head connector. The blood collection channel can be in fluid communication with the head connector.
• Another illustrative embodiment of an infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient, comprises a blood collection component; a housing having an actuator and an IV infusion inlet coupled to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation for the device; a microlumen collocated with the patient catheter, the microlumen in fluid communication with the IV infusion inlet; a blood collection channel in fluid communication with the catheter; and a passive restriction device limiting the volume flow rate of blood drawn by the catheter in the infusion/collection mode, thereby preventing mixing of the blood draw with IV therapy fluid provided through the microlumen; and wherein in the infusion/non-collection mode the actuator fluidly couples the blood collection channel with the IV infusion inlet, and in the infusion/collection mode the actuator fluidly isolates the blood collection channel from the IV infusion inlet.
• The passive restriction device can be a thin, elongate tube fluidly coupling the blood collection component and blood collection channel. The microlumen can be positioned coaxially within the catheter and the distal end of the microlumen extend distally beyond the distal end of the catheter. The blood collection component can fluidly couple a vacuum blood collection tube to the blood collection channel. The blood collection component can be releasably attachable to the housing. The actuator can be actuated to the infusion/collection mode by engagement of the blood collection component with the housing and the actuator can be actuated to the infusion/non-collection mode by disengagement of the blood collection component with the housing. The engagement can include axial and rotational movement of the blood collection component relative to the housing, the axial movement placing the elongate tube in fluid communication with the blood collection component and the rotation movement operating the actuator.
• Yet another illustrative embodiment of an infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient, comprises a housing having an actuator and an IV infusion inlet coupled to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation for the device; a microlumen positionable coaxially through the patient catheter, the distal end of the microlumen extending distally beyond the distal end of the catheter the microlumen, and the microlumen in fluid communication with the IV infusion inlet; a blood collection channel in fluid communication with the catheter; and a blood collection tube holder releasably attachable to the housing and having a draw needle, the draw needle selectively in fluid communication with the blood collection channel in the infusion/collection mode, and the draw needle providing a restriction limiting the volume flow rate of blood drawn by the catheter in the infusion/collection mode, thereby preventing mixing of the blood draw with IV therapy fluid provided through the microlumen; and wherein in the infusion/non-collection mode the actuator fluidly couples the blood collection channel with the IV infusion inlet, and in the infusion/collection mode the actuator fluidly isolates the blood collection channel from the IV infusion inlet.
BRIEF DESCRIPTION OF THE DRAWINGS
• The detailed description particularly refers to the accompanying figures in which:
• FIG. 1 is a perspective assembly view of a first illustrative embodiment of an infusion and blood collection device as used with an IV infusion line and a Peripheral Venous Catheter;
• FIG. 2A is a schematic diagram of the fluid system of the device ofFIG. 1 in an infusion/non-collection mode of operation;
• FIGS. 2B and 2C is a schematic diagram of the fluid system of the device ofFIG. 1 in an infusion/collection mode of operation;
• FIG. 3 is a perspective exploded view of the valve housing portion of the device ofFIG. 1;
• FIG. 4 is a perspective exploded view of the blood collection tube holder portion of the device ofFIG. 1;
• FIG. 5 is a top perspective assembly view of the device ofFIG. 1 before use;
• FIG. 6 is a bottom perspective assembly view of the device ofFIG. 1 before use and with the protective cap removed from overtop the microlumen;
• FIG. 7A is perspective assembly view of the device ofFIG. 1 placed with an IV infusion line and a Peripheral Venous Catheter, the device in an infusion/non-collection mode and the tube holder being prepared to be coupled with the valve housing;
• FIG. 7B is a cross-sectional view of the valve housing and separated tube holder taken along sectionalcutting plane line7B-7B, shown inFIG. 7A, and with the device in the infusion/non-collection mode;
• FIG. 7C is a cross-sectional view of the valve housing taken along sectionalcutting plane line7C-7C, shown inFIG. 7B, and with the device in the infusion/non-collection mode;
• FIG. 8A is perspective assembly view of the device ofFIG. 1, the device in an infusion/non-collection mode and the tube holder being coupled with the valve housing and not yet rotated;
• FIG. 8B is a cross-sectional view of the valve housing and coupled tube holder taken along sectionalcutting plane line8B-8B shown inFIG. 8A, and with the device in the infusion/non-collection mode;
• FIG. 8C is a cross-sectional view of the valve housing taken along sectionalcutting plane line8C-8C shown inFIG. 8B, and with the device in the infusion/non-collection mode;
• FIG. 9A is perspective assembly view of the device ofFIG. 1, the device actuated to the infusion/collection mode and the tube holder being coupled with the valve housing and rotated, and a blood collection tube coupled with the tube holder;
• FIG. 9B is a cross-sectional view of the valve housing and coupled tube holder and collection tube taken along sectionalcutting plane line9B-9B, shown inFIG. 9A, and with the device in the infusion/collection mode;
• FIG. 9C is a cross-sectional view of the valve housing taken along sectionalcutting plane line9C-9C, shown inFIG. 9B, and with the device in the infusion/collection mode;
• FIG. 10A is perspective assembly view of the device ofFIG. 1, the device returned to the infusion/non-collection mode and the tube holder reverse-rotated and being uncoupled from the valve housing;
• FIG. 10B is a cross-sectional view of the valve housing and coupled tube holder taken along sectionalcutting plane line10B-10B, shown inFIG. 10A, and with the device in the infusion/non-collection mode;
• FIG. 10C is a cross-sectional view of the valve housing taken along sectionalcutting plane line10C-10C, shown inFIG. 10B, and with the device in the infusion/non-collection mode;
• FIG. 11 is a perspective assembly view of a second illustrative embodiment of an infusion and blood collection device of the invention herein, illustratively shown installed between an IV infusion line and a Peripheral Venous Catheter;
• FIG. 12 is a perspective view of the transfer and collection assembly of the second embodiment of the device ofFIG. 11;
• FIG. 13 is a perspective view of the catheter head assembly of the second embodiment of the device ofFIG. 11;
• FIG. 14 is a top perspective view of the transfer valve and collection body of the second embodiment of the device ofFIG. 11;
• FIG. 15 is bottom perspective view of the collection tube holder of the second embodiment of the device ofFIG. 11;
• FIG. 16 is a top perspective view of the transfer valve housing of the second embodiment of the device ofFIG. 11;
• FIG. 17 is a top perspective view of the transfer valve housing ofFIG. 16 with the rotary valve actuator removed;
• FIG. 18 is a semi-transparent top view of the transfer valve housing ofFIG. 17 showing the infusion and collection channels in the device;
• FIG. 19 is a perspective view of the rotary valve and actuator of the transfer valve housing ofFIG. 17;
• FIG. 20 is a semi-transparent top view of the transfer valve housing ofFIG. 17 in the infusion/non-collection mode and showing IV flow in all channels;
• FIG. 21 is a semi-transparent top view of the transfer valve housing ofFIG. 17 in the infusion/collection mode and showing IV flow in the IV channel and blood flow in the blood collection channel;
• FIG. 22 is a cross-sectional view of the transfer valve housing and tube holder ofFIG. 12 taken along sectional cutting plane line22-22;
• FIG. 23 is a cross-sectional view of the catheter Head assembly ofFIG. 13 taken along sectional cutting plane line23-23;
• FIG. 24 is a cross-sectional view of the catheter Head assemblyFIG. 13 taken along sectional cutting plane line24-24 and showing IV flow in the IV channel and blood flow in the blood collection channel inside the assembly;
• FIG. 25 is an enlarged partial cross-sectional view of the tip of the catheter and microlumen ofFIG. 24 showing the microlumen tip protruding beyond the tip of the catheter;
• FIG. 26 is a transparent top view of the transfer valve housing ofFIG. 16 in the infusion/non-collection mode and showing IV flow in all channels;
• FIG. 27 is semi-transparent cross-sectional view of the transfer valve housing ofFIG. 26 taken along sectional cutting plane line27-27 and showing the infusion/non-collection mode;
• FIG. 28 is a transparent top view of the transfer valve housing ofFIG. 16 in the infusion/collection mode and showing IV flow in the IV channel and blood flow in the blood collection channel;
• FIG. 29 is semi-transparent cross-sectional view of the transfer valve housing ofFIG. 28 taken along sectional cutting plane line29-29 and showing the infusion/collection mode;
• FIG. 30A is a cross-sectional view of the needleless draw port of the device ofFIG. 11, taken along sectional cutting plane line30A-30A shown inFIG. 31A, and with the device in the infusion/non-collection mode;
• FIG. 30B is a cross-sectional view of the needleless draw port cooperating with the needleless draw nozzle of the device ofFIG. 11, taken along sectional cutting plane line30A-30A shown inFIG. 31A, and with the device in the infusion/collection mode;
• FIG. 31A is a bottom axial view of the needleless draw port of the device ofFIG. 11, with the device in the infusion/non-collection mode; and
• FIG. 31B is a bottom axial view of the needleless draw port cooperating with the needleless draw nozzle of the device ofFIG. 11, with the device in the infusion/collection mode.
DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
• For the purposes of promoting and understanding the principals of the invention, reference will now be made to one or more illustrative embodiments depicted in the drawings and specific language will be used to describe the same. Referring toFIGS. 1-10 in the Drawings section, these figures show a first illustrative embodiment of an infusion andblood collection device100 of the invention herein, Thedevice100 is illustratively shown as used, coupled between a standardIV infusion line10 and astandard catheter20, for example, a peripheral venous catheter placed in a vein of a patient's arm or hand. An example of such astandard catheter20 is the shielded IV catheter product number 381534, also known as the BDInsyte Autoguard Winged 20 gauge catheter, available from Becton, Dickson and Company (BD), of Sandy, Utah.
• It is understood that in a typical situation requiring venous catheterization of a patient in, e.g., an emergency room or hospital, theIV infusion line10 and thecatheter20 would be connected directly together via a releasable fluid connector, typically a Luer Lock type connector having a male portion (not shown) at aproximate end24 of thecatheter20, and afemale connector11 portion at theproximate end12 of the IV infusion line. TheIV infusion line10 is typically connected on the opposite, distal end to an IV therapy bag (not shown) and/or infusion pump (not shown), and adistal end22 of thecatheter20 is inserted into a patient blood vessel, e.g., in the patient's arm or hand as shown inFIGS. 1 and 2A-2C, for example, using a sharp insertion needle introducer (not shown), the needle of which is extended through and extends beyond thedistal end22 of thecatheter20, and is extracted from the catheter after placement of the distal end into a patient'svein23. An example of such an introducer is product number 384010, also known as the BD Introsyte Autoguard Shielded Introducer, available from Becton, Dickson and Company (BD), of Sandy, Utah. After placement of thecatheter20, the infusion andblood collection device100 of the present invention is simply installed in between theIV infusion line10 and thecatheter20, coupled via theconnectors11 and65, as is discussed below.
• The illustrative embodiment of the infusion andblood collection device100 of the present invention comprises the following main components, depicted inFIGS. 1, 3 and 6: acollection tube holder30 for receiving a standardvacuum collection tube15, avalve housing40 enclosing avalve80 and including an intravenous infusion (IV)inlet43 and acatheter head63, ashroud70 for coupling thetube holder30 to thevalve housing40, and optional retaining supports90 for securing anIV infusion line10 and thevalve housing40 to a patient's arm.
• Materials from which thetube holder30,valve housing40,shroud70,valve80, and retainingsupports90 can be formed, include, for example, medical grade plastics and structural polymer material such as ABS, Polyurethane, Polycarbonate, PBT, PEI, PEEK, Polypropylene, PET, and the like. For example,tube holder30,valve housing40, andshroud70 can be formed from Polycarbonate andvalve80 can be formed from Polypropylene.
• Theintravenous infusion inlet43 includes a separate or integrally formedmale connector42 for fluid coupling with thefemale connector11, for example a Luer Lock fitting, ofIV infusion line10. Thecatheter head63 includes afemale connector65, for example a Luer Lock fitting, for fluid coupling with thecatheter20. Thecatheter head63 also includes anintravenous infusion microlumen60, which is fluidly coupled toIV infusion channel58, and ablood collection channel54, theoutlet64 of which is fluidly coupled to catheter20 (FIGS. 6 and 7C).
• FIGS. 2A-2C illustrate schematic diagrams of anillustrative fluid system101 of thedevice100 according to the present invention. With reference to thedevice100, ablood collection channel54 and aninfusion channel58 extend betweenIV inlet43 andcatheter head63. As described above, thecatheter head63 is coupled to anIV catheter20, which is earlier placed in aperipheral vein23 of a patient, and thecatheter head63 also includes themicrolumen60. Upon coupling of thecatheter head63 with theconnector24 of thecatheter20, themicrolumen60 is inserted coaxially within the interior of thecatheter20. For reasons more fully described below, the relative lengths of thecatheter20 and themicrolumen60 are such that adistal end62 of the microlumen60 protrudes from and extends distally beyond thedistal end22 of thecatheter20, thus extending axially farther along and within the patient'svein23, as shown inFIG. 2C. Themicrolumen60 is in fluid communication with theinfusion channel58. Thecatheter20, or more specifically for thedevice100, the radial space between the outside surface of themicrolumen60 and the interior surface of thecatheter20, is in fluid communication with theblood collection channel54 via outlet64 (FIGS. 6 and 7C). A microlumen60 having at least a minimum amount of rigidity while remaining flexible enough to remain safely within thecatheter20 andvein23 has been found to be advantageous in threading themicrolumen60 into theconnector24 andcatheter20. For example, a microlumen formed from braided and coated PTFE, such as product code 165-III available from Microlumen of Oldsmar, Fla.
• Advantageously, thedevice100 provides selective operation in an infusion/non-collection mode and an infusion/collection mode. As shown inFIG. 2A, in the infusion/non-collection mode,IV fluid14 is provided simultaneously fromIV inlet43 to each of theinfusion channel58, including themicrolumen20, and theblood collection channel54, includingcatheter20, of thefluid system101. In the infusion/non-collection mode of operation,IV fluid14 flows into the fluid system at theIV inlet43 and simultaneously exits within thevein23 at the respective distal ends22 and62 of thecatheter20 andmicrolumen60.
• In contrast and as shown inFIGS. 2B and 2C, in the infusion/collection mode of operation, theblood collection channel54 of thedevice100 is closed off from theIV inlet43 and thus from the supply ofIV fluid14. The fluid isolation of theIV inlet43 from theblood channel54 can be implemented by any one of various mechanical or electromechanical actuators known in the art. For example, in the illustrative first embodiment of thedevice100, a two-way rotary valve80 (FIG. 3) rotates from a non-collection valve position83ain which thevalve passage84a(FIGS. 2A and 7C) is fluidly coupled to both theIV inlet43 and theblood channel54, to a collection valve position83bin which thevalve passage84a(FIGS. 2B and 9C) is fluidly isolated from theIV inlet43 but remains fluidly coupled to theblood channel54. Thevalve passage84athus forms a portion of theblood collection channel54 in both valve positions83aand83b.
• As shown inFIG. 2B, once theblood collection channel54 is closed off from theIV fluid14, a vacuum blood collection tube is fluidly coupled with theblood collection channel54 via an outlet, for example, aneedle channel84b. The vacuum of thecollection tube15 drawsblood18 into thecatheter20, or more specifically from the space between thecatheter20 andmicrolumen60 as shown inFIG. 2C, through theblood collection channel54 and into thecollection tube15. The collection ofblood18 occurs simultaneous with and without interruption of the infusion ofIV therapy fluid14 through theinfusion channel58, exiting into thevein23 of the patient at thedistal end62 of themicrolumen60.
• Asblood18 is drawn from thevein23 into thecatheter20, the fluid entering thecollection tube15 initially will beIV fluid14, and then a mixture ofIV fluid14 andblood18, and then onlyblood18. Thus, thefirst collection tube15 filled from theblood collection channel54 is discarded and a subsequently filledblood collection tube15 that contains onlyblood18 and noIV fluid14 are retained. After a sufficient sample ofblood18 is obtained from thedevice100, thecollection tube15 is fluidly uncoupled from theblood collection channel54, and if desired,subsequent collection tubes15 are coupled, filled, and uncoupled, and then therotary valve80 is returned to the non-collection valve position83a, fluidly recoupling theblood collection channel54 with thetherapy fluid14 from theIV inlet43, thereby again providing the infusion/non-collection mode ofFIG. 2A in whichIV fluid14 is simultaneously provided to each of thecatheter20 and themicrolumen60.
• Referring toFIG. 2C, thedistal end62 of themicrolumen60 is shown protruding distally from within thedistal end22 of thecatheter20. The length of thedistal portion62 of the microlumen60 that protrudes from thedistal end22 of thecatheter20 is illustratively around 10 mm, but it can vary depending on various fluid dynamic features of thedevice100, including the type and model ofcatheter20 andmicrolumen62 used, and the desired blood collection flow rate. The protrusion length and blood collection flow rate are of significant importance to the invention herein, in order to prevent mixing atdistal end22, and thus contamination, of the drawnblood18 with theIV fluids14, as will become apparent from the discussion below. For example, atypical IV catheter20 is 18 or 20 gauge, and amicrolumen60 providing the desired functionality when axially inserted within thecatheter20 is about 24 to 25 gauge.
• Referring toFIG. 3, an exploded perspective view of thevalve housing40 is illustrated.Valve housing40 includes ahousing top44 and a housing bottom45 that together define avalve cavity50, IVinfusion channel portions58aand58b, and ablood collection channel54. Thevalve housing40 provides continuous fluid communication throughinfusion channel58a, thus continuously providingIV fluid14 presented atIV inlet43 to each of theoutlet64 and themicrolumen60. Thevalve cavity50 sealingly houses therotary valve80, which provides IV fluid14 toblood collection channel54 selectively in the non-collection mode of operation. For example, thevalve body82 may include a sealing ridge orother feature85 that prevents seepage of fluids and thevalve body82 and/orvalve cavity50 may be coated with a sealing and/or lubricating material prior to assembly, for example silicone spray or gel, or may include an elastomeric sealing layer.
• Therotary valve80 includes avalve body82 that defines avalve passage84ahaving openings connecting to opposite sides of the valve body (FIGS. 3 and 7C). Thevalve body82 further defines a draw port81 that is fluidly plugged by and retains septum76 (FIG. 3) and tube holder engagement features86 and87 that will be described further below.
• The draw port81 at a bottom77 of theseptum76 is fluidly coupled to thevalve passage84abyneedle passage84b(FIG. 7B). Referring toFIGS. 7B and 7C, when thevalve80 is enclosed within the assembledhousing top44 andhousing bottom45 and thevalve80 is in a non-collection position83a(FIG. 7C) thevalve passage84aof thevalve80 fluidly couples theinfusion channel portion58bto theblood collection channel54, supplyingIV fluid14 to thecatheter head63 andcatheter20. Referring toFIG. 9C, when thevalve80 is rotated to a collection position83bthevalve passage84aofvalve80 is fluidly isolated from theinfusion channel portion58byet remains in fluid communication with theblood collection channel54, thus providing a path forblood18 entering thedistal end22 of thecatheter20 to be supplied to thevalve passages84a, theneedle channel84band the bottom77 of theseptum76.
• Referring toFIG. 4, thecollection tube holder30 provides an adaptor to couple ablood collection tube15 to thevalve housing40, and also functions to actuate thevalve80 between the non-collection position83a(FIG. 8C) for the infusion/non-collection mode of operation and collection position83b(FIG. 9C) for the infusion/collection mode of operation. Thetube holder30 includes an insertion and rotation handle31, acentral tube receptacle32, atube stop33 at the base of the receptacle, adraw port interface36, and adraw needle34. Referring toFIG. 7B, thedraw needle34 extends through thetube stop33 and has atop end34aextending above thetube stop33 and upwardly into thetube receptacle32. Thedraw needle34 also extends downwardly below thetube stop33 and within thecentral area39 enclosed by thedraw port interface36. Thedraw port interface36 functions in part to encircle and prevent injury from the sharplower end34bof theneedle34.
• Thetube holder interface36 is configured to fit within anopening46 in thevalve housing40 and engage with thevalve80 andhousing40 upon coupling thetube holder30 andshroud70 to thevalve housing40. In the first illustrative embodiment of thedevice100, the engagement of thetube holder30 with thevalve housing40 and thevalve80 provides axial positioning of thedraw needle34 and rotation of thevalve80. More specifically, the engagement axially extends thedraw needle34 through the septum bottom77 and theneedle channel84band into thevalve passage84a, as shown inFIG. 9B. Additionally, the engagement rotates thevalve80 andvalve housing40 from the infusion/non-collection valve position83ato the infusion/collection valve position83b. Optionally, mechanical features can be provided with thetube holder30,housing40, and/or thevalve80 so that mechanical detents or other sensory feedback is provided that indicated the range of limits of full rotation and/or axial translation to ensure proper use and operation.
• Referring toFIGS. 3, 4 and 7B, thetube holder interface36 defines various engagement features, includingaxial draw tabs37,rotational slots38, and acentral area39. Thevalve housing40 defines various engagement features, including theopening46,draw tab receivers47, and drawramps48. Thevalve80 defines various engagement features, includingreceiver86 androtational cogs37. The function and interaction of the various engagement features will be described further below in the operation of thedevice100.
• The series ofFIGS. 7A-7C, 8A-8C, 9A-9C, and 10A-10C illustrate the various steps and stages of the infusion/non-collection mode of operation, preparing thedevice100 for a blood draw, drawing blood into collection tube(s)15 in the infusion/collection mode of operation, and returning thedevice100 to the infusion/non-collection mode of operation.
• Referring toFIG. 7A, in the following illustrative use of theillustrative device100, the installation of the infusion andblood collection device100 for intravenous therapy of a patient is described. Prior to installation of thedevice100, following standard techniques well-known in the art, the peripheralvenous catheter20 is typically inserted into a vein of the patient and theIV therapy tube10 is connected via a Luer-type orother connection11. To install the infusion andblood collection device100 in-line with thecatheter20 so that clean blood samples can be periodically drawn from the patient via thecatheter20, the IVtherapy fluid flow14 throughIV infusion line10 is stopped, and the peripheralvenous catheter20 is disconnected from theIV infusion line10. Thevalve housing40 of the device is connected to theIV infusion line10 by connecting theconnector11 to theinlet port43 and thefluid flow14 through theIV infusion line10 is then restarted, and the IV fluid14 (or e.g., heparin) flowing intoinlet port43 fills both theblood collection channel54 and theinfusion channel58 in thehousing40 until theIV fluid14 flows from thecatheter head63, thus pushing all air from thechannels54 and58. The protective cap96 (FIG. 5) can be removed from thecatheter head63, exposing themicrolumen60, for example, by actuatingrelease98.
• Thecatheter head63 can then be attached to the catheter20 (which, for example, has remained in the patient) by inserting themicrolumen60 all the way through thecatheter20 and tightening the Luer-type orother connector65 onto themale catheter connector63, thus allowing theIV therapy fluid14 to infuse into the patient from both thecatheter20 and themicrolumen60. Advantageously, thevalve housing40 can be grasped from above and held in the palm while therelease98 is actuated, themicrolumen60 guided, and theconnector65 rotated bywing66 all with the free thumb and/or forefinger of the hand holding thevalve housing40, freeing the other hand to apply pressure to thevein23 to prevent blood flow through thecatheter20 from the uncoupling of theIV line connector11 until the coupling of thedevice100connector65. With the optionally retainingsupports90 coupled atclips92 to valve housing receivers94 (FIG. 3) as shown inFIG. 1, medical tape can be applied oversurface91 and around the patient's arm to hold thevalve housing40 in place. Advantageously, thevalve housing40 can include ridges or other protrusions defined by the housing bottom45 to limit skin contact or risk of skin breakdown. Additionally, to allow drainage of any liquids entering theopening46 when thetube holder30 is not in place, and minimize the possibility of microbial growth,drainage channels51 extending downward from within theopening46 can be defined through thehousing40.
• Alternatively and advantageously, thedevice100 can also be installed in-line with thecatheter20 upon thecatheter20 first being placed and before anIV infusion line10 is connected to thecatheter20. For example, as described above, thedevice100 can be connected to theIV infusion line10 and flushed of air with theIV fluid14. Then, with thedevice100 prepared, the peripheralvenous catheter20 can be placed into a vein of the patient and thecatheter head63 attached to thecatheter20 as described above.
• Referring now toFIGS. 7A-7C, thedevice100 is shown in the infusion/non-collection mode of operation after installation in-line withIV line10 and thecatheter20. Specifically, thetube holder30 andshroud70 are uncoupled from thevalve housing40 and therotary valve80 is in the infusion/non-collection rotational position83a(FIG. 7C) in whichIV fluid14 provided at theinlet43 is simultaneously provided to each of theblood collection channel54 and theinfusion channel58a, and thus simultaneously flows in the patient'svein23 from each ofcatheter20 andmicrolumen60.
• To prepare thedevice100 for the infusion/collection mode of operation, an alcohol or other sterilizing swab is used to clean theseptum76 and the area within theopening46 to remove any contaminates. Next thetube holder30, without ablood collection tube15 attached, is coupled to thevalve housing40. Specifically, theaxial draw tabs37 are rotationally aligned with thedraw tab receivers47 and thetube holder30 is moved vertically downwards in the direction shown inFIGS. 7A and 7B, engaging thetabs37 through thereceivers47 and into draw ramps48 and engaging theside flanges72 around thevalve housing40. Theshroud70 and thetube holder30 is releasably retained to thevalve housing40 by the engagement ofprotrusions71 intorecesses41 located on each side of thevalve housing40. Additionally, and as shown inFIGS. 8B and 8C, in this position, thelower end34bof thedraw needle34 has not penetrated theseptum76 and therotary valve80 remains in the infusion/non-collection rotational position83a. As shown inFIG. 8A, theflanges72 can define friction elements such as ridges to facilitate holding thedevice100 securely during the subsequent below steps.
• To complete the axial translation of thelower end34bof thedraw needle34 through theseptum76 and into thevalve passage84a, thetube holder30 is rotated clockwise relative to thevalve housing40 as shown inFIG. 8A. Referring now toFIGS. 9B and 9C, showing thedevice100 with rotation complete, rotation of thetube holder30 rotates thedraw tabs37 within the draw ramps48 of thehousing40. The draw ramps48 spiral downward so that the rotation results in thetube holder interface36 translating axially downward farther into thevalve housing40 to the position shown inFIG. 9B in which thelower end34bof thedraw needle34 pierces theseptum76 and extends into thevalve passage84a. Additionally, rotation of theinterface36 with thetube holder30 rotates thevalve80 since thecogs87 are engaged withinslots38 of theinterface36. This rotation rotates thevalve80 to the infusion/collection position83bshown inFIG. 9C, in whichvalve passage84a(FIGS. 2B and 9C) is fluidly isolated fromIV inlet43 but remains fluidly coupled to theblood channel54. Mechanical stops (not shown), for example, the ends of the draw ramps48 contacted by thedraw tabs37 prevent over rotation of thevalve80 in the clockwise and counter-clockwise directions.
• Optionally, an initial length of the draw ramps48 defined in thevalve housing40 and engaged by thedraw tabs37 can extend circumferentially without downward axially displacement in order to provide for some or all of the rotation of thevalve80 before subsequent axial translation of theinterface36 andneedle34, thus ensuring that the fluid connection between thelower needle end34band thevalve passage84ais not made until thevalve passage84ais closed off from theinfusion channel portion58band thus from the supply of theIV fluid14.
• As shown inFIGS. 9A and 9B, once theblood collection channel54 is closed off from theIV fluid14, a vacuumblood collection tube15 is fluidly coupled with theblood collection channel54 vianeedle channel84bandvalve passage84a. More specifically, in pushing a collection tube downward intotube receptacle32 and against the tube stop33 of thetube holder30, theseptum16 of thecollection tube15 pushes theelastomeric needle cover35 downward, exposing the upper needle end34aallowing it to pierce thecollection tube septum16. The vacuum of thecollection tube15 drawsblood18 into thecatheter20, as shown inFIG. 2C, through theblood collection channel54,valve passage84a,needle34, and into thecollection tube15.
• Advantageously, the collection ofblood18 occurs simultaneous with and without interruption of infusion ofIV therapy fluid14 throughinfusion channel58, exiting into thevein23 of the patient at thedistal end62 of themicrolumen60. Thecollection tube15 is uncoupled from thetube holder30, and if desired,subsequent collection tubes15 are coupled, filled, and uncoupled. With the lack of a vacuum, a passive fluid flow restriction provided byneedle34, and theelastomeric cover35 again covering theupper end34aof theneedle34,blood18 will cease to flow throughneedle34 with nocollection tube15 in place. For example, the flow restriction can be provided by the selected ID of theneedle34, by crimping theneedle34 to a specific desired cross-sectional area, or by other mechanically passive means known in the art to limit flow.
• To return thedevice100 to the infusion/non-collection mode of operation, as shown inFIGS. 10B and 10C,tube holder30 is rotated counter-clockwise and theshroud70 andtube holder30 are separated from thevalve housing40, as shown inFIG. 10A. Rotating thetube holder30 counter-clockwise returns therotary valve80 to the non-collection valve position83a, fluidly recoupling theblood collection channel54 with thetherapy fluid14 from theIV inlet43.
• Rotating thetube holder30 counter-clockwise also axially translates theinterface36 andneedle34 upwardly as thedraw tabs37 are spiraled upward within draw ramps48. When thedraw tabs37 are again aligned with47, the rotation is complete andinterface36 can be fully withdrawn from theopening46 and theflanges72 withdrawn from over thevalve housing40, as shown inFIG. 10B. Advantageously, theseptum76 is self-sealing, so that when theneedle34 is withdrawn and theIV fluid14 flows through thevalve passage84awithout escaping at theseptum76.
• Again in the infusion/non-collection mode of operation shown inFIG. 10C,IV fluid14 is again simultaneously provided to each of thecatheter20 and themicrolumen60, flushing theblood collection channel54 of theblood18 earlier drawn into it, and providing for continuing use of thedevice100. Thus, advantageously, theblood collection channel54, including thevalve passage84a, are self-flushing in that the return to the infusion/non-collection mode flushes any remaining blood through thecatheter20 with the flow ofIV fluid14, thus preventing any coagulation and potential blockage or other hazards ofblood18 associated with thedevice100. Because thedraw needle34 associated with thetube holder30 is not flushed, it is discarded and anew tube holder30 is utilized when another blood draw from the patient is desired.
• One aspect of the first embodiment of the invention herein relates to one of the novel features of the infusion andblood collection device100 and method, which is the ability to perform clean blood collections while simultaneously providing the patient with IV therapy infusion, without interrupting the IV fluid flow. In one aspect, thedevice100 is designed so as to prevent contamination of theblood18 being drawn with theIV fluids14. The ability of thedevice100 to provide this function is due in part to two features of the device: 1) a protrusion of the tip of the microlumen60 in thevein23, an optimum minimum distance beyond the tip of the catheter20 (seeFIG. 2C); 2) a related restriction in the flow in theblood18 being collected when therotary valve80 is rotated to the collection position83b.
• In an illustrative embodiment of these foregoing features, for example, thedistal tip62 ofmicrolumen60 extends 10 mm beyond thedistal tip22 of thecatheter20, paired with a restriction in theblood collection channel54 to reduce the blood collection flow rate to 30 ml/min or less, provides sufficient protection against theIV fluids14 flowing out from thedistal tip62 of the microlumen60 being drawn toward and mixed in with theblood18 being drawn into thedistal tip22 of thecatheter20 for collection in thecollection tube30.
• As contemplated herein, it is to be understood that both the length of the protrusion of the tip of the microlumen relative to the tip of the catheter, and the degree of restriction ofblood flow18, may vary upward or downward depending on various factors such as, for example, the particular gauge ofcatheters20 and60 being used, the vacuum pressure in theparticular collection tube30, the venous or arterial location of thecatheter20 in the patient, and the rate of infusion ofIV therapy fluid14 out themicrolumen60. Thus, for example, with a protrusion length shorter than 10 mm, the flow rate would correspondingly have to be further restricted and decreased, and with a protrusion length longer than 10 mm, the flow rate may be increased correspondingly.
• In regard to the restriction ofblood flow18 to reduce the blood collection flow rate to the point that the IV fluid flow is not reversed in the vein and drawn into the blood collection catheter, this restriction can be accomplished in various ways known in the art and at various locations along the path of the flow of theblood18 between thedistal end22 ofcatheter20 and theblood collection tube15, either active restriction device, passive restriction device, or a combination of active and passive restriction devices. In the above illustrative embodiment of thedevice100, the restriction in flow rate is made passively via the choice of the gauge of thepenetration needle34 that penetrates the end of the collection tube, thus a needle is selected having a sufficiently narrow internal diameter to provide the required limit to blood flow rate. In theillustrative device100 with thedistal end62 of the microlumen60 extending 10 mm beyond thedistal end22 ofcatheter20, a restriction limiting the flow rate to about 30 ml/minute provides the desired lack of contamination of the blood sample collected. This desired restriction is passively provided by using apenetration needle34 having a gauge of about 24. For example, such aneedle34 can be cut from a length of stainless steel 304 hypodermic round tubing stock, for example, part number B00137QIWS, available from Amazon.com, LLC, of Seattle, Wash.
• The volume flow rate (Q) of theblood18 is driven by the change in pressure (ΔP) for theblood18 between the patient and thecollection tube15, and most notably in the illustrative embodiment of thedevice110, at the point of passive restriction in theblood flow18, thedraw needle34. In order to specify a needle gauge that will limit the volume flow rate (Q) to the desired magnitude, e.g., about 30 ml/min or less for the illustrative embodiment, the fluid dynamic principles for laminar flow with an applied force and no-slip boundary condition between a desired blood volume flow rate (Q) and a pressure gradient (ΔP) can be used. This relationship is represented in the Hagen-Poiseuille equation which is Q=πa⁴ΔP/8ρμL, where a, L, ρ, μ are in this example, the interior radius and length of theneedle136, and the density and viscosity of the blood, respectively.
• Referring toFIGS. 11 and 13 in the Drawings section, these figures show a perspective view of a second illustrative embodiment of an illustrative infusion andblood collection device110 of the invention herein, illustratively installed between a standardIV infusion line10 and astandard catheter20, for example, a peripheral venous catheter. An example of such astandard catheter20 is the shielded IV catheter product number 381703, also known as theBD Angiocath Autoguard 20 gauge, available from Becton, Dickson and Company (BD), of Sandy, Utah.
• The illustrative embodiment of the infusion andblood collection device110 of the present invention comprises the following main components, depicted inFIG. 11. Acollection tube holder120 for receiving a standardvacuum collection tube15, a transfer valve andcollection body140, an intravenous infusion inlet143 (FIG. 12) for fluid coupling with theIV infusion line10, ablood collection lumen150, anintravenous infusion lumen160, and acatheter head assembly200 for fluid coupling with thecatheter20. Theblood collection lumen150 andintravenous infusion lumen160 couple thecatheter head assembly200 to the transfer valve andcollection body140.
• FIG. 12 illustrates thetube holder120,vacuum collection tube15, and transfer valve andcollection body140, assembled together, andFIG. 13 illustrates thecatheter head assembly200, including acatheter head body202. The distal end of thecatheter head body202 includes aconnector204 for coupling the connector83 (FIG. 23) at theproximate end24 of a standardvenous catheter20. Additionally,catheter head assembly200 comprises an attached, microlumen210 that passes coaxially through the interior ofcatheter20.
• Thecatheter head body202 provides fluid coupling between the microlumen210 andblood collection lumen150 and between thecatheter20 and theintravenous infusion lumen160.FIG. 23 is a cross-sectional side view ofcatheter head assembly200 and illustrates the internal passageways250 and260 defined bybody202. Blood collection passageway250 retains and is in fluid communication with theblood collection lumen150 and with thecatheter20, or more specifically, the open space between the interior of thecatheter20 and exterior of themicrolumen210. Infusion passageway260 retains and is in fluid communication withintravenous infusion lumen160 and themicrolumen210.
• A blood collection channel152 is defined in part by the passage defined by the space between thecatheter20 andmicrolumen210, the passageway250, and thelumen150. An infusion channel162 is defined in part by themicrolumen210, the passageway260, and thelumen160. As will be discussed in greater detail below, the blood collection channel152 is used to provide infusion flow to the patient when thedevice110 is in an infusion/non-collection mode, and, as discussed below, for reverse flow ofblood18 from the patient to thecollection tube15, when thedevice110 is in an infusion/collection mode. On the other hand, the infusion channel162 is used in either mode only for one-way infusion flow to the patient, as is discussed below.
• InFIGS. 23-25, thedistal end212 of themicrolumen210 is shown protruding distally out from thedistal end22 of thecatheter20.FIG. 25 is an enlarged, partial view of thedistal tip portion22 ofcatheter20, and more clearly illustrates the protrudingdistal portion212 of themicrolumen210. The length of thedistal portion212 of themicrolumen210 that protrudes from thedistal end22 of thecatheter20 is illustratively around 10 mm, but it can vary depending on the type and model of catheter used and the desired blood collection flow rate. The protrusion length and blood collection flow rate are of significant importance to the invention herein, in order to prevent mixing, and thus contamination, of the drawnblood18 with theIV fluids14, as will become apparent from the discussion below. For example, atypical catheter20 is 18 or 20 gauge, and amicrolumen210 providing the desired functionality when axially inserted withincatheter20 is about 24 to 25 gauge.
• FIGS. 11 and 13 also illustrate thecatheter head assembly200, including a microlumen stabilizer pull handle206 (omitted from the views illustrated inFIGS. 23 and 24). Pullhandle206 is connected to a wire or pin (not shown) that is inserted through the interior ofmicrolumen210, providing rigidity to themicrolumen210 andcatheter20 for insertion of the respective distal ends212 and22 into the patient. After successful patient insertion, thepull handle206 is actuated proximately along its axis, thereby extracting the wire or pin (not shown) from the interior ofmicrolumen210, reducing rigidity. It is understood that the technique of catheter insertion can follow the standard technique for catheter insertion that is well-known in the art.
• Reference is made again toFIG. 12, which illustrates a close-up perspective view of the assembledtube holder120,vacuum collection tube15, and transfer valve andcollection body140.FIGS. 14 and 15 illustrate the transfer valve andcollection body140 and thetube holder120, respectively, disassembled from one another. A perspective view of the bottom side of thetube holder120 is shown inFIG. 15. Transfer valve andcollection body140 encloses a transfer valve housing142 (seeFIG. 16 below), including a valve assembly180 (partially shown inFIG. 19, and discussed in greater detail below), and a locking interface having keyedopenings141aandretention flanges141bfor locating and retaining thetube holder120 relative to thevalve assembly180. Specifically, the retention wings122 (FIG. 15) protruding radially fromactuator receiver124 on a bottom of thetube holder120 are received through thekeyed openings141a, and upon thetube holder120 being rotated relative to the transfer valve andcollection body140, theretention wings122 rotate under theretention flanges141bto retain thetube holder120 firmly to the transfer valve andcollection body140.
• Referring toFIGS. 14, 19, 22, 27, and 29, thevalve assembly180 includes arotary valve182, avalve actuator184, anelastomeric valve layer190, and a portion of thehousing top144. Theactuator184 is spaced apart from and rotationally fixed with therotary valve182 by acentral shaft181. Theelastomeric valve layer190 and portion ofhousing top144 are fixed relative to thehousing140, and therefore do not rotate with therotary valve182,actuator184, andshaft181. Actuator184 (FIGS. 14 and 16) defines an opening comprising alatch boss receiver186 that engagingly receives latch boss148 (FIG. 17), and further defines an elongated, arcuate opening comprising a drawport interface receiver188 that engagingly receives the draw port interface130 (FIG. 15) of thetube holder120.
• Thetube holder120 also comprises alatch actuation key126 and an elongated, arcuatedraw port interface130, both located within theactuator receiver124. Thedraw port interface130 is positioned and sized to fit precisely into drawport interface receiver188 upon mounting thetube holder120 to the transfer valve andcollection body140. Likewise,latch actuation key126 is positioned and sized to fit precisely into thelatch boss receiver186 upon mounting thetube holder120 to the transfer valve andcollection body140. Drawport interface130 further comprises a recessed alcohol orother disinfectant swab134 and aneedleless draw nozzle132.
• Referring now toFIG. 16, this figure shows a top perspective view of thetransfer valve housing142 as it would appear if removed from the transfer valve andcollection body140.Transfer valve housing142 includes ahousing top144 and ahousing bottom145.Transfer valve housing142 also houses avalve assembly180 comprising anvalve actuator184 and a rotary valve182 (not shown inFIG. 16) rigidly held together with ashaft181, and thehousing top144 and anelastomeric valve layer190 there between (thevalve assembly180 is discussed in greater detail in connection withFIG. 19 below). Materials from which thehousing142,tube holder120,actuator184, andvalve182 can be formed, include, for example, structural polymer material such as ABS, Polyurethane, Polycarbonate, PBT, PEI, PEEK, Polypropylene, PET, and the like. Materials from which theelastomeric layer190 can be formed, include, for example, thermoplastic urethane, thermoplastic vulcanizate, PEBA, TPE, RTV Silicone, and the like.
• Thehousing top144 includes anopening146 for receiving the valve assemblycentral shaft181 there through and acurved latch cantilever147 at the distal tip of which is located alatch boss148. Thelatch boss148 cooperates with thelatch boss receiver186 of thevalve actuator184 to rotationally lock thevalve assembly180 relative to thehousing142 andelastomeric valve layer190. Thehousing top144 also includes aneedleless draw port154 from which ablood collection flow18 is provided to thetube holder120 during a particular operating mode described further below.
• Referring now toFIG. 19, this figure shows thevalve assembly180 with itsvalve actuator184,rotary valve182, andshaft181. As discussed above,valve actuator184 defines thelatch boss receiver186 and the drawport interface receiver188 for the draw port.Rotary valve182 is shown inFIG. 19 to definetransfer channel183. Thevalve182 andactuator184 are spaced apart to fit precisely on opposite sides of thehousing top144 andelastomeric valve layer190, as is best illustrated inFIGS. 22, 27, and 29, with thehousing top144 located between the actuator184 and theelastomeric valve layer190, theelastomeric valve layer190 located between thehousing top144 and therotary valve182, and therotary valve182 located between theelastomeric valve layer190 and thehousing bottom145. The precise sizing and positioning of the various features on thevalve182,elastomeric valve layer190,actuator184, and the features of thehousing top144 is of substantive importance, as discussed above and below.
• FIG. 18 and various subsequent FIGS. shows a semi-transparent view of thetransfer valve housing142, including fluid passageways defined by portions of thehousing top144,elastomeric valve layer190,rotary valve182. These fluid passageways are selectively in fluid communication with the incomingIV infusion line10 viainlet143, theinfusion lumen160, theblood collection lumen150, and theneedless draw port154. Specifically, and referring toFIGS. 21 and 28, the blood collection channel152, described in part above, is further defined by ablood collection passageway194, including bloodcollection transfer orifice195, and drawport154. Theblood collection lumen150,passageway194,transfer orifice195, and drawport154 are always in fluid communication for both operating modes, namely the infusion/non-collection mode illustrated inFIGS. 26-27, and the infusion/collection mode illustrated inFIGS. 28-29. Additionally, the infusion channel162, described in part above, is further defined by theinfusion passageway197, including theinfusion transfer orifice196. Theinfusion lumen160,passageway197,transfer orifice196,inlet143, andIV infusion line10 are likewise always in fluid communication for both operating modes.
• In contrast, selective fluid communication is provided depending on the rotational location of thevalve assembly180 andtube holder120 relative to thetransfer valve housing142. Before mounting of thetube holder120 to the transfer valve andcollection body140, therotary valve182 andvalve actuator184 are in their counterclockwise most position, shown inFIGS. 16 and 26-28. This relative position provides the infusion/non-collection mode of operation, in which thetransfer channel183 defined by therotary valve182 is in arotational position183a, shown best inFIG. 27, but also shown inFIGS. 20 and 26, which provides unrestricted fluid communication between theinfusion transfer orifice196 and theblood collection orifice195, the function of which will be further described below.
• Upon mountingtube holder120 to the transfer valve andcollection body140, including full available clockwise rotation of thetube holder120,valve actuator184, androtary valve182, the infusion/collection mode of operation is provided, in which thetransfer channel183 is located in therotation position183b, shown inFIGS. 21 and 28-29, which provides fluid isolation between theinfusion transfer orifice196 and theblood collection orifice195, and thus, fluid isolation through all of the blood collection channel152 and the infusion channel162. Additionally, in the infusion/collection mode of operation, theneedleless draw nozzle132 is in fluid communication with theneedleless draw port154, and thus the blood collection channel152 is further defined in this operating mode by theneedleless draw nozzle132 andtube penetration needle136.
• Selection between the infusion/non-collection mode and the infusion/collection mode is provided by the mounting and clockwise rotation, and the counter-clockwise rotation and unmounting of thetube holder120 with the transfer valve andcollection body140, including the associated function of various interoperative structures resulting from the mounting and rotation.
• Upon thetube holder120 being mounted to the transfer valve andcollection body140, thevalve actuator184 is received into the actuator receiver124 (FIG. 15), and thelatch actuation key126 extends downward into thelatch boss receiver186, from the side opposite that from which theboss148 ofcantilever147 upwardly extends into thelatch boss receiver186, pressing theboss148 downward and clear of thelatch boss receiver186. Furthermore, when thetube holder120 is mounted to the transfer valve andcollection body140 thedraw port interface130 fits precisely into drawport interface receiver188. To mount thetube holder120 to the transfer valve andcollection body140, the two are brought together, fitting the matching and retention features as described above, and theholder120 is rotated so as to engage the tubeholder retention wings122 under theretention flanges141b.
• FIG. 22 shows a cross-sectional cut-off view of thetube holder120 and the transfer valve andcollection body140 assembled together.FIG. 22 also shows the collectiontube penetration needle136 that is coupled to thetube holder120, projecting upwardly into the center oftube receptacle128, and in fluid communication with theneedleless draw nozzle132.FIG. 22 also illustrates the collectiontube penetration needle136 penetrating thecover17 portion of thecollection tube15 that is inserted axially into thetube receptacle128 so that ablood sample18 can be collected therein. The figure shows the assembly in the normal, non-blood-collection mode, wherein theneedleless draw nozzle132 does not overlap theneedleless draw port154. In this infusion/non-collection mode, thevalve assembly180 functions to provide theIV fluid14 flowing intoinlet143 fromIV infusion line10 into both channels152 and162, and thus bothlumens150 and160, as shown inFIG. 20, and continues on in both channels through both thecatheter20 and microlumen210 and into the patient's vein.
• In the following illustrative use of theillustrative device110, the installation of the infusion andblood collection device110 during intravenous therapy of a patient is described. Prior to installation of thedevice110, following standard techniques well-known in the art, the peripheralvenous catheter20 is typically inserted into a vein of the patient and theIV therapy tube10 is connected via a Luer-type orother connection11. To install the infusion andblood collection device110 in preparation for drawing clean blood samples from the patient via thecatheter20, the IVtherapy fluid flow14 throughIV infusion line10 is stopped, and the peripheralvenous catheter20 is disconnected from theIV infusion line10. The transfer valve andcollection body140 of the device is connected to theIV infusion line10 by connecting theconnector11 to theinlet port143.
• Referring toFIGS. 26-27, illustrating use of thedevice110 in the infusion/non-collection mode of operation, thefluid flow14 through theIV infusion line10 is then restarted, and the IV fluid14 (or e.g., heparin) flowing intoinlet port143 fills both the blood collection channel152 and the infusion channel162 in thehousing142,lumens150 and160, passageways250 and260 defined by thecatheter head body202, until theIV fluid14 flows from thecatheter head assembly200, thus pushing all air from the channels152 and162.
• Thecatheter head assembly200 can then be attached to the catheter20 (which, for example, has remained in the patient) by inserting themicrolumen210 all the way through thecatheter20 and tightening the Luer-type orother connector204 onto themale connector83, as shown inFIG. 23. The microlumen stabilizer pullhandle206 is then pulled, retracting the wire or pin from the interior of themicrolumen210, and with the IV therapy resumed, thus allowing theIV therapy fluid14 to infuse into the patient from both thecatheter20 and the microlumen210 (not precisely illustrated).
• The infusion/non-collectiontransfer channel position183afunctions to provideIV fluid flow14 from theIV infusion line10 through both the blood collection line/channel150/152 and the IV infusion line/channel160/162. Referring toFIGS. 20 and 26, theIV fluid14 flows from theIV infusion line10 through to theinfusion conduit197, where it is free to flow intoinfusion orifice196 and flow out through the two pathways: theinfusion line160 and also through thetransfer channel183, through theblood collection orifice195, intoblood collection conduit194 and out theblood collection line150. Before thetube holder120 is coupled to transfer valve andinfusion body140 thetransfer channel183 on thevalve assembly180 is in the infusion/non-collection position183aand theblood collection port154 is closed off fromfluid14 escaping the port.
• More specifically, and referring toFIGS. 30A and 30B, theblood collection port154 can be sealed by the design of an elastomericcentral portion155 havingslits157 and that is bulbous downward toward the source of internal pressure of the fluid14, and wherein the internal pressure of the fluid14 cooperates with the geometry of thecentral portion155 to more tightly seal theport154, preventing an opening156 (FIGS. 30B and 31B) from forming between theslits157. Alternatively, or additionally, the bottom surface ofvalve actuator184 against which thetop surface158 of thecentral portion155 rests when thedevice110 is in the infusion/non-collection mode can act to seal or to further seal theport154, preventing an opening156 (FIGS. 30B and 31B) from forming between theslits157.
• In the following illustrative use of theillustrative device110, the use of the infusion andblood collection device110 to drawblood18 from the patient and into acollection tube30 without interrupting the IV therapy of the patient is described. Thedevice110 is installed between IVtherapy infusion line10 andpatient catheter20 and flushed off all air as described above. Atube holder120, disassembled from the transfer valve andcollection body140, is held in one hand, and a heat sealed tab (not shown) sealing over the blooddraw port interface130 is pulled away from thetube holder120, exposing theinterface130, including thealcohol swab134 and the previously sterilizeddraw nozzle132.
• Next, theretention wings122 of thetube holder120 are aligned to thekeyed openings141aof the transfer valve andcollection body140. This also aligns thedraw port interface130 with theinterface receiver188, and also aligns thelatch boss receiver186 with thelatch actuation key126. Thetube holder120 is pressed firmly into position, so that thevalve actuator184 is received into theactuator receiver124, which presses thelatch actuation key126 into thelatch boss receiver186, deflecting the latch boss148 (including cantilever147) downward so that it is flush with the top surface of thehousing top144, and thus axially out from thelatch boss receiver186 so that the valve actuator184 (including therotary valve182 and elastomeric valve layer190) may rotate. In this position thedraw port interface130 is also seated within theinterface receiver188 of thevalve actuator184, thus rotating thevalve actuator184 androtary valve182 as thetube holder120 is rotated clockwise relative to thehousing140.
• With thelatch boss148 disengaged from thelatch boss receiver186, thetube holder120 can be rotated clockwise relative to the transfer valve andcollection body140, rotating theretention wings122 under theretention flanges141buntil thewings122 reach a rotational stop (not shown), retaining thetube holder120 in place on the transfer valve andcollection body140.
• During the clockwise rotation of thetube holder120 relative to the transfer valve andcollection body140, several critical events occur: (1) Theneedleless draw port154 located on the face of thehousing top144 is drawn under theramp131 portion of thedraw port interface130, and across thealcohol swab134, thus wiping and cleaning theneedleless draw port154. (2) Theneedleless nozzle154 is moved into axial alignment with theneedleless draw port132, cooperating to open and seal upon thedraw port132, thus allowing collectedblood18 to flow therebetween. (3) Thetransfer channel183 on therotary valve182 of thevalve assembly180 is rotated from the infusion/non-collection moderotational position183ashown inFIGS. 26-27 (connecting the blood collection channel152 and the IV infusion channel162), and to the infusion/collection moderotational position183bshown inFIGS. 26-27, isolating the blood collection channel152 from the IV infusion channel162.
• This can be clearly seen by comparingFIGS. 20 and 21 or 26 and 28, showing the flow pattern of theIV fluid14 through the transfer valve andcollection body140 with thetransfer channel183 connecting channels152 and162 in the non-collectionrotational position183a, withFIGS. 21 and 29, showing the flow pattern of theIV fluid14 andblood18 through the transfer valve andcollection body140 with thetransfer channel183 moved into thecollection position183b, which isolates the channels152 and162. As can be seen inFIGS. 21, 24, and 28-29, with thetransfer channel183 in theblood collection position183b,IV therapy fluid14 infusion through the infusion channel162 and outmicrolumen210 continues without being inhibited, as shown inFIG. 25.
• More specifically, and referring toFIGS. 30A and 30B, theblood collection port154 can be sealed by the design of an elastomericcentral portion155 havingslits157 and that is bulbous downward toward the source of internal pressure of the fluid14, and wherein the internal pressure of the fluid14 cooperates with the geometry of thecentral portion155 to more tightly seal theport154, preventing an opening156 (FIGS. 30B and 31B) from forming between theslits157. Alternatively, or additionally, the bottom surface ofvalve actuator184 against which thetop surface158 of thecentral portion155 rests when thedevice110 is in the infusion/non-collection mode can act to seal or to further seal theport154, preventing an opening156 (FIGS. 30B and 31B) from forming between theslits157.
• The next step in this illustrative use entails placing thecollection tube30 into thetube receptacle128 of thetube holder120 and pressing downward into the position shown inFIG. 22, allowing thepenetration needle136 to pierce thecollection tube cover32 and the vacuum in thetube30 to pullblood18 via the blood collection channel152, namely, through the collectiontube penetration needle136, theneedleless nozzle132, theneedleless draw port154 which thenozzle132 seals, thepassageway194, thetransfer orifice195, thedraw channel lumen150, the passageway250 defined by thecatheter head body202, and between thecatheter20 and themicrolumen210, as shown inFIGS. 24-25 and 28-29.
• Referring toFIGS. 30B and 31B, in the infusion/collection mode, theblood collection port154 is actuated by achamfered protrusion133adefined at a distal end of theneedleless draw nozzle132 and sized and shaped to cooperate to open theblood collection port154. More specifically, thetop surface158 of the elastomericcentral portion155 is pressed axially downward by theprotrusion133a, deforming thecentral portion155 and allowing anopening156 to form between theslits157, thus allowingblood18 to flow upwardly through theaxial channel133bin thenozzle132 and on through thepenetration needle136 and into thecollection tube130.
• Once the desired volume ofblood18 is collected intocollection tube30, thecollection tube30 is extracted from the tube receptacle138, and thetube holder120 is grasped in one hand and the transfer valve andcollection body140 in the other, thetube holder120 is rotated counterclockwise relative to thebody140 and separated therefrom. This rotation and separation rotates thevalve actuator182 and therotary valve184 to the counterclockwise position shown inFIGS. 20 and 26-27, reengaging thelatch boss148 into thelatch boss receiver186, thereby again locking thedevice110 in the infusion/non-collection mode, in which theneedleless draw nozzle132 is also rotated out of alignment with theneedleless draw port154, allowing thedraw port154 to again be sealed, preventing opening156 from forming. In the infusion/non-collection mode, the blood collection channel152 and infusion channel162 are again in fluid communication via therotational position183aof thetransfer channel182, and theIV therapy fluid14 is again provided to both channels152 and162 (FIG. 26), flushing the blood collection channel152 of theblood18 earlier drawn, and providing for reuse of thedevice110 with a new or sterilizedtube holder120 andcollection tube30.
• In regard to the restriction ofblood flow18 to reduce the blood collection flow rate to the point that the IV fluid flow is not reversed in the vein and drawn into the blood collection catheter, as with thedevice100, fordevice110 this restriction can be accomplished in various ways known in the art and at various locations along the blood collection channel152, either active restriction device, passive restriction device, or a combination of active and passive restriction devices. In the above illustrative embodiment of thedevice110, the restriction in flow rate is made passively via the choice of the gauge of thepenetration needle136 that penetrates the end of the collection tube, thus a needle is selected having a sufficiently narrow internal diameter to provide the required limit to blood flow rate. In theillustrative device110 with themicrolumen210 extending 10 mm beyond the blood collection entry atcatheter20, a restriction limiting the flow rate to about 30 ml/minute provided the desired lack of contamination of the blood sample collected. This desired restriction was passively provided by using apenetration needle136 having a gauge of about 24. In another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by using a tesla-type valve located anywhere along the blood collection channel152, including located in thehousing142.
• In another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by utilizing a check valve with a tuned reverse flow rate in lieu of a typical shut off, located anywhere along the blood collection channel152.
• In yet another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by utilizing a length of channel of reduced diameter to create the required restriction, located anywhere along the blood collection channel152.
• In still another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by having a reduction in clearance between the outside of themicrolumen210 and the inside of thecatheter20.
• In still another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by use of a multi-lumen catheter (venous or arterial) in lieu of a typical peripheralintravenous catheter20 andmicrolumen210, but with a draw channel offset and of sufficiently small diameter and length to restrict the flow and prevent a diluted draw.
• In still another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by the use of an active device, which restricts the flow of theblood18 to a collection device, located anywhere along the blood collection channel152. Illustratively, the active device can include a pump, which draws the blood and presents the blood to thecollection tube30.
• In still another embodiment, it is contemplated herein that the required blood collection flow restriction may be accomplished by having a diaphragm, needle, or other such valve actuated either by electronics or manually to create a restriction located anywhere along the blood collection channel152.
• Another embodiment of the invention herein relates to the novel feature of using a valve to segregate two or more infusion channels into a blood collection channel152 and intravenous therapy infusion channel162, as illustrated above. An illustrative embodiment of this feature is the use of a rotary valve as illustrated above.
• In another embodiment, it is contemplated herein that an alternative valve type may be used. Illustratively, the valve may be a cock-stop type valve, a diaphragm type valve, an electrically actuated solenoid type valve, or a magnetic actuated valve.
• In another embodiment, described herein is a rotary blood-draw valve with locking features, as illustrated herein, to prevent access to the blood collection port by patients, e.g., pediatric or agitated patients or patients suffering from various forms of dementia, or having other elevated risks relating to additional needle insertions.
• In another embodiment, described herein is a sliding blood-draw valve with locking features, to prevent access to the blood collection port by patients, e.g., pediatric or agitated patients or patients suffering from various forms of dementia, or having elevated risks relating to additional needle insertions.
• In another embodiment, described herein is a collection tube holder with integrated alcohol swipe and means to clean the blood collection access port via sliding or rotating the tube holder into place prior to the draw and after the draw, as illustrated above.
• It is understood that, while the illustrative embodiments of thedevices100 and110 are directed to an angiocatheter (i.e., an IV catheter), as contemplated herein, various features or combinations of features disclosed herein may be applicable to other catheters as well, such as peripherally inserted cardiac catheters, central line catheters, and the like. In the case of use with a cardiac catheter, it is understood that the required draw rate would differ because of the geometry of the vein and the blood flow rate in that region; however, thesame device110 and system can be used for controlling the blood collection rate, and a suitable protrusion length of the microlumen tip beyond the catheter tip could be easily determined and used. Additionally, it is understood that features of one of thedevices100 and110 can be applied to the other device.

Claims (20)

1. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient, comprising:

a blood collection component having a draw inlet;

a housing having an actuator and an IV infusion inlet coupled to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation for the device;

a microlumen collocated with the patient catheter, the microlumen in fluid communication with the IV infusion inlet;

a blood collection channel in fluid communication with the catheter, the blood collection channel directly accessible by the draw inlet of the blood collection component; and

wherein in the infusion/non-collection mode the actuator fluidly couples the blood collection channel with the IV infusion inlet, and in the infusion/collection mode the actuator fluidly isolates the blood collection channel from the IV infusion inlet.

2. The infusion and blood collection device ofclaim 1, wherein the blood collection channel is self-flushing with IV therapy fluid in the infusion/non-collection mode.

3. The infusion and blood collection device ofclaim 1, further comprising a passive restriction device limiting the volume flow rate of blood drawn by the catheter in the infusion/collection mode, thereby preventing mixing of the blood draw with IV therapy fluid provided through the microlumen.

4. The infusion and blood collection device ofclaim 1, wherein the blood collection component is releasably attachable to the housing.

5. The infusion and blood collection device ofclaim 4, wherein the actuator is actuated to the infusion/collection mode by engagement of the blood collection component with the housing and the actuator is actuated to the infusion/non-collection mode by disengagement of the blood collection component with the housing.

6. The infusion and blood collection device ofclaim 4, wherein the engagement includes axial and rotational movement of the blood collection component relative to the housing, the axial movement placing the draw inlet in fluid communication with the blood collection component and the rotation movement operating the actuator.

7. The infusion and blood collection device ofclaim 1, wherein the draw inlet includes a needle positionable to extend into the blood collection channel in the infusion/collection mode.

8. The infusion and blood collection device ofclaim 1, wherein the blood collection component fluidly couples a vacuum blood collection tube to the blood collection channel.

9. The infusion and blood collection device ofclaim 1, wherein the actuator includes a rotary valve.

10. The infusion and blood collection device ofclaim 9, wherein the rotary valve is a two-way valve and defines at least a portion of the blood collection channel.

11. The infusion and blood collection device ofclaim 10, where the draw inlet of the blood collection component is extendable into the portion of the blood collection channel defined by the rotary valve.

12. The infusion and blood collection device ofclaim 1, wherein the microlumen extends past the distal end of the catheter such that a distal end of the microlumen is located distally beyond the distal end of the catheter.

13. The infusion and blood collection device ofclaim 12, wherein the microlumen is threaded coaxially through the catheter.

14. The infusion and blood collection device ofclaim 13, wherein:

the patient catheter includes a fluid catheter connector;

the housing includes a fluid head connector for coupling to the catheter connector;

the microlumen exits the housing from within the head connector; and

the blood collection channel is in fluid communication with the head connector.

15. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient, comprising:

a blood collection component;

a housing having an actuator and an IV infusion inlet coupled to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation for the device;

a microlumen collocated with the patient catheter, the microlumen in fluid communication with the IV infusion inlet;

a blood collection channel in fluid communication with the catheter; and

a passive restriction device limiting the volume flow rate of blood drawn by the catheter in the infusion/collection mode, thereby preventing mixing of the blood draw with IV therapy fluid provided through the microlumen; and

wherein in the infusion/non-collection mode the actuator fluidly couples the blood collection channel with the IV infusion inlet, and in the infusion/collection mode the actuator fluidly isolates the blood collection channel from the IV infusion inlet.

16. The infusion and blood collection device ofclaim 15, wherein the passive restriction device is a thin, elongate tube fluidly coupling the blood collection component and blood collection channel.

17. The infusion and blood collection device ofclaim 15, wherein the microlumen is positioned coaxially within the catheter and the distal end of the microlumen extends distally beyond the distal end of the catheter.

18. The infusion and blood collection device ofclaim 15, wherein:

the blood collection component fluidly couples a vacuum blood collection tube to the blood collection channel;

the blood collection component is releasably attachable to the housing; and

the actuator is actuated to the infusion/collection mode by engagement of the blood collection component with the housing and the actuator is actuated to the infusion/non-collection mode by disengagement of the blood collection component with the housing.

19. The infusion and blood collection device ofclaim 18, wherein the engagement includes axial and rotational movement of the blood collection component relative to the housing, the axial movement placing the elongate tube in fluid communication with the blood collection component and the rotation movement operating the actuator.

20. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient, comprising:

a housing having an actuator and an IV infusion inlet coupled to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation for the device;

a microlumen positionable coaxially through the patient catheter, the distal end of the microlumen extending distally beyond the distal end of the catheter the microlumen, and the microlumen in fluid communication with the IV infusion inlet;

a blood collection channel in fluid communication with the catheter; and

a blood collection tube holder releasably attachable to the housing and having a draw needle, the draw needle selectively in fluid communication with the blood collection channel in the infusion/collection mode, and the draw needle providing a restriction limiting the volume flow rate of blood drawn by the catheter in the infusion/collection mode, thereby preventing mixing of the blood draw with IV therapy fluid provided through the microlumen; and

wherein in the infusion/non-collection mode the actuator fluidly couples the blood collection channel with the IV infusion inlet, and in the infusion/collection mode the actuator fluidly isolates the blood collection channel from the IV infusion inlet.

Images